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The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

Primary Purpose

Uterine Fibroids

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

Mifegyne

placebo

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring mifepristone, leiomyomas, breast epithelial cell proliferation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Uterine fibroids requiring treatment

Good general health
Willing and able to participate after giving informed consent

Exclusion Criteria:

Need for immediate surgery
Concomitant hormonal treatment (HRT)
History of malignant disorder of the breast
Any contraindication for mifepristone

Criteria for retrospective exclusion:

Subjects may be excluded from analysis if one of the following applies:

Any violation of the study protocol
Lack of essential data

Sites / Locations

Dept of Obstetrics and Gynecology, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Arm Description

Mifepristone (Mifegyne) 50 mg every other day for 3 months

Outcomes

Primary Outcome Measures

Myoma size

Secondary Outcome Measures

Breast epithelial cell proliferation

Full Information

NCT ID

NCT00579475

First Posted

December 21, 2007

Last Updated

May 22, 2015

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT00579475

Brief Title

The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

Official Title

The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Uterine fibroids are a benign but common condition among women in reproductive age. It is one of the most common reasons for hysterectomy since it often causes bleeding problems sometimes leading to anemia. Several alternative treatment regimens have been investigated that could replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that have been tested. In addition to the inhibiting effect on the growth of uterine fibroids antiprogestins have been proposed to have an antiproliferative effect on breast tissue. The purpose of the present study is to evaluate the effect of mifepristone on the volume of uterine fibroids. The study will also address the effect of mifepristone on the breast tissue

Detailed Description

Other purposes of this study include: To develop a new non-surgical method for treatment of uterine fibroids To study the effect of mifepristone on the size of uterine fibroids To evaluate factors regulating fibroid growth by comparison with untreated fibroids and normal myometrium To study the effect of mifepristone on the amount of blood loss and pelvic pain in patients with fibroids To study the effect of mifepristone on proliferation of breast tissue

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Fibroids

Keywords

mifepristone, leiomyomas, breast epithelial cell proliferation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Arm Description

Mifepristone (Mifegyne) 50 mg every other day for 3 months

Intervention Type

Drug

Intervention Name(s)

Mifegyne

Intervention Description

tablets, 50 mg every other day

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Myoma size

Time Frame

2004 to 2007

Secondary Outcome Measure Information:

Title

Breast epithelial cell proliferation

Time Frame

2004 to 2007

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Uterine fibroids requiring treatment Good general health Willing and able to participate after giving informed consent Exclusion Criteria: Need for immediate surgery Concomitant hormonal treatment (HRT) History of malignant disorder of the breast Any contraindication for mifepristone Criteria for retrospective exclusion: Subjects may be excluded from analysis if one of the following applies: Any violation of the study protocol Lack of essential data

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristina Gemzell Danielsson, Prof.MD.PHD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Obstetrics and Gynecology, Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

SE17176

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

29890128

Citation

Berger C, Boggavarapu N, Norlin E, Queckborner S, Hornaeus K, Falk A, Engman M, Ramstrom M, Lalitkumar PGL, Gemzell-Danielsson K. Molecular characterization of PRM-associated endometrial changes, PAEC, following mifepristone treatment. Contraception. 2018 Oct;98(4):317-322. doi: 10.1016/j.contraception.2018.05.020. Epub 2018 Jun 8.

Results Reference

derived

PubMed Identifier

24324590

Citation

Engman M, Varghese S, Lagerstedt Robinson K, Malmgren H, Hammarsjo A, Bystrom B, Lalitkumar PG, Gemzell-Danielsson K. GSTM1 gene expression correlates to leiomyoma volume regression in response to mifepristone treatment. PLoS One. 2013 Dec 4;8(12):e80114. doi: 10.1371/journal.pone.0080114. eCollection 2013.

Results Reference

derived

PubMed Identifier

19389793

Citation

Engman M, Granberg S, Williams AR, Meng CX, Lalitkumar PG, Gemzell-Danielsson K. Mifepristone for treatment of uterine leiomyoma. A prospective randomized placebo controlled trial. Hum Reprod. 2009 Aug;24(8):1870-9. doi: 10.1093/humrep/dep100. Epub 2009 Apr 23.

Results Reference

derived

PubMed Identifier

18579510

Citation

Engman M, Skoog L, Soderqvist G, Gemzell-Danielsson K. The effect of mifepristone on breast cell proliferation in premenopausal women evaluated through fine needle aspiration cytology. Hum Reprod. 2008 Sep;23(9):2072-9. doi: 10.1093/humrep/den228. Epub 2008 Jun 24.

Results Reference

derived

Learn more about this trial

The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

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